Abrocitinib Provides Atopic Dermatitis Clearance Despite Age, Dose at 96 Weeks

Article

Contrary to short-term phase 3 research, the JAK-1 inhibitor was not dose-dependent nor less effective in older adult patients over nearly 2 years.

Abrocitinib Provides Atopic Dermatitis Clearance Despite Age, Dose at 96 Weeks

Andrew F. Alexis, MD, MPH

Credit: Weill Cornell

Oral janus kinase 1 (JAK-1) inhibitor abrocitinib provided long-term efficacy in moderate to severe atopic dermatitis treatment among adult patients—regardless of older age status.1

In new late-breaking abstract data presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC, investigators reported findings from a 96-week post hoc analysis of the phase 3 JADE EXTEND trial showing dose-dependent response to abrocitinib levels out among older adult patients with atopic dermatitis after approximately 1 year of treatment.

The long-term outcomes provide an extent of relief to clinicians over concerns regarding the potential age- and dose-dependent outcomes associated with the JAK-1 inhibitor for adults with moderate to severe atopic dermatitis.

Presented by study Andrew F. Alexis, MD, MPH, vice chair for diversity and inclusion for the department of dermatology and professor of clinical dermatology at Weill Cornell Medical College, the study was conducted in order to interpret efficacy outcomes of abrocitinib over 96 weeks in adult patients with moderate to severe atopic dermatitis who previously participated in JADE EXTEND.

Prior research has established abrocitinib as a dose-dependent beneficial therapy for such patients over 12 – 16 weeks of treatment—not an uncommon circumstance associated with available agents for the chronic disease.

“The disease course and clinical phenotypes of atopic dermatitis vary across different patient age groups, suggesting that treatment response may depend on the age of the patient,” Alexis and colleagues wrote. “In adult patients, atopic dermatitis is more prevalent and moree likely to be active and severe in older individuals.”

The prespecified interim analysis included JADE EXTEND participants—by which part patients from the phase 3 JADE clinical program (MONO-1, MONO-2, COMPARE, DARE) were enrolled by a September 2021 cutoff. The extension trial patients maintained their 200 mg or 100 mg once-daily abrocitinib regimens from previous randomizations, while patients who previously received placebo were randomized to either regimen.

Investigators identified 2 age groups (18 – 50 years vs >50 years) at the time of screening visit. Key assessments in the 96-week analysis included treatment responses per Investigators Global Assessment (IGA) scores of 0 or 1, Eczema Area Severity Index (EASI) 75 or 90, Peak Pruritus Numerical Rating Scale (NRS) improvements of ≥4 points, and Dermatology Life Quality Index (DLQI) scores of 0 or 1.

The assessment included 1046 patients aged 18 – 50 years old, and 263 patients aged >50 years old. A majority of patients in the 4 age- and dose-stratified arms were male; mean disease duration was >20 years.

The following proportions of patients per arm achieved IGA 0 or 1 after 96 weeks of their abrocitinib regimen:

  • Patients >50 years old on 200 mg abrocitinib: 58%
  • Patients 18 – 50 years old on 200 mg abrocitinib: 55%
  • Patients >50 years old on 100 mg abrocitinib: 51%
  • Patients 18 – 50 years old on 100 mg abrocitinib: 44%

Proportions of patients per arm to achieve EASI-75 at 96 weeks were as follows:

  • Patients >50 years old on 200 mg abrocitinib: 89%
  • Patients 18 – 50 years old on 200 mg abrocitinib: 86%
  • Patients >50 years old on 100 mg abrocitinib: 85%
  • Patients 18 – 50 years old on 100 mg abrocitinib: 73%

Proportions of patients per arm to achieve Peak Pruritus NRS ≥4-point scores at 96 weeks were as follows:

  • Patients >50 years old on 200 mg abrocitinib: 80%
  • Patients 18 – 50 years old on 200 mg abrocitinib: 79%
  • Patients >50 years old on 100 mg abrocitinib: 66%
  • Patients 18 – 50 years old on 100 mg abrocitinib: 54%

Alexis and colleagues noted that the dose-dependent disparity in abrocitinib efficacy observed early into patient regimens were less distinct after 48 weeks. They concluded that the interim extension trial findings may better help clinicians navigate long-term atopic dermatitis treatment plans with patients.

References

  1. Alexis AF, Deleuran M, Silverberg JI, Gooderham MJ, et al. Long-Term Efficacy of Abrocitinib up to 96 Weeks in Adults With Moderate-to-Severe Atopic Dermatitis Stratified by Age: A Post Hoc Analysis of the JADE EXTEND Phase 3 Trial. Paper presented at: Revolutionizing Atopic Dermatitis 2023 Spring Conference; April 29 – May 1, 2023; Washington, DC. Accessed April 30, 2023.
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